Another phase III failure of Theravance Biopharma Inc.’s norepinephrine reuptake inhibitor ampreloxetine to treat symptomatic neurogenic orthostatic hypotension, this time in patients with the rare disease multiple system atrophy, means the end of the company’s R&D efforts. Cutting its workforce in half and terminating all development of ampreloxetine, its only pipeline product, the Dublin-based company’s shares (NASDAQ:TBPH) sank by 26%, or $4.99, to close March 3 at $13.96. Read More

A lot of distance lies between talking regulatory flexibility and actually being flexible. That message was driven home again after Uniqure NV disclosed in its latest earnings report March 2 that the U.S. FDA wants a sham-controlled study before it will consider approval of the company’s gene therapy AMT-130 in Huntington’s, a rare disease currently affecting about 41,000 people in the U.S. Read More

China’s National Medical Products Administration has approved Sino Biopharmaceutical Ltd.’s rovadicitinib, branded as Anxu, for first-line treatment of adults with intermediate- or high-risk primary myelofibrosis, as well as post polycythemia vera myelofibrosis or post-essential thrombocythemia myelofibrosis. Read More

Boehringer Ingelheim GmbH is stopping development of OSE Immunotherapeutics SA’s BI-770371 in metabolic dysfunction-associated steatohepatitis (MASH), after the SIRPα antagonist failed to show efficacy in a phase II study. Codevelopment of BI-770371 will continue for oncology indications, however, which was the initial target of the duo’s €1.4 billion (US$1.6 million) partnership in 2018. Read More

Radnet Inc. acquired Gleamer SAS for up to €230 million (US$267 million) as it continues to expand its position across imaging and acute diagnostic care, while accelerating its move toward AI-powered automated diagnostics. Gleamer will be integrated into Radnet’s subsidiary, Deephealth Inc., strengthening its imaging portfolio, and positioning the company as the world’s largest provider of radiology clinical AI solutions. Read More

Quell Therapeutics Ltd. has delivered the first clinical data indicating its chimeric antigen receptor (CAR) T regulatory cell therapy, QEL-001, can enable liver transplant patients to be weaned off long-term immunosuppression. Read More

Oddsmakers wasted no time figuring the market chances after Merck & Co. Inc. rolled out data from the phase III Litespark-011 study testing its oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, Welireg (belzutifan), when used with tyrosine kinase inhibitor Lenvima (lenvatinib, Eisai Co.) in advanced renal cell carcinoma. Read More

Computational pathology, which assesses molecular-level features of diseases directly from tissue images (rather than testing the tissue via methods such as staining or sequencing) is making rapid strides. Read More

Vanda Pharmaceuticals Inc. will get to take its argument for twice-rejected jet lag disorder drug Hetlioz (tasimelteon) before the U.S. FDA in a formal evidentiary public hearing, a rare move by the agency that the firm claims underscores the “gravity of the legal and scientific issues” it has raised. Read More

New hires and promotions in the biopharma and med-tech industries, including: 3T, Apellis, Argo, Conexeu, Nautilus, Nrx, Shoulder Innovations, Wisdom. Read More

Biopharma and med-tech companies raising money in public or private financings, including: Beone, Defence, Edison, Jazz, Royalty, Sharp, Telo Genomics, Zymeworks. Read More

Clinical updates for biopharma and med tech, including data readouts and publications: Aardvark, Abbvie, Bayer, Bioxytran, Celldex, Cogent, DBV, Longbio, Merck, Opus, Rhythm, Roche, Septerna, United, Upstream. Read More

Biopharma and med-tech happenings, including deals and partnerships, and other news in brief: Bioatla, Blueprint, Celyn, Cullgen, Deephealth, Disc, Gyre, Kairos, Medimaps, Opgen, Pulmatrix, Radiobiotics. Read More

Regulatory snapshots for biopharma and med tech, including global submissions and approvals, and other regulatory decisions and designations: Abbott, Agios, Ascendis, Biomarin, Innocare, Innovent, Intellia, Merck, Novo Nordisk, Protagonist, Sanofi, Scibase, Takeda, Uniqure. Read More